Control system for arterial catheter

ABSTRACT

A control system for an arterial catheter operable to selectively impede blood flow includes a processor and a storage medium accessible to the processor that bears instructions which when executed by the processor cause the processor to execute logic including receiving a first signal representing a physical parameter associated with a patient in whom the catheter is disposed, receiving a second signal representative of time, and causing inflation of a first balloon on the catheter to impede blood flow in the first artery. Based at least in part on the first signal satisfying a first condition, the instructions include causing deflation of the first balloon. Based at least in part on the second signal indicating elapse of a predetermined time period, the instructions include causing deflation of the first balloon regardless of whether the first signal satisfies the first condition.

This application incorporates by reference in its entirety U.S. patentapplication Ser. No. 11/042,639 (now U.S. Pat. No. 7,867,195), filedJan. 24, 2005.

I. FIELD OF THE INVENTION

The present application relates generally to control systems forarterial catheters.

II. BACKGROUND OF THE INVENTION

As recognized in the above-referenced U.S. patent (U.S. Pat. No.7,867,195), incorporated herein by reference in its entirety,selectively blocking certain arteries for limited time can result inincreased blood flow through other arteries for therapeutic purposes. Asunderstood herein, automating some or all of the inflation protocol canprovide additional advantages.

SUMMARY OF THE INVENTION

It is to be understood that placement of balloons on a catheter inaccordance with present principles is not limited to, but can be in/oncatheter positions described in U.S. Pat. No. 7,867,195 for augmentingarterial flow.

Accordingly, a control system for an arterial catheter operable toselectively impede blood flow in a first artery to increase blood flowin a second artery includes at least one processor, and at least onecomputer readable storage medium accessible to the processor. Thecomputer readable storage medium bears instructions which when executedby the processor cause the processor to execute logic includingreceiving a first signal representing a physical parameter associatedwith a patient in whom the catheter is disposed, receiving a secondsignal representative of time, and causing inflation of a first balloonon the catheter to impede blood flow in the first artery. Based at leastin part on the first signal satisfying a first condition, theinstructions include causing deflation of the first balloon. Based atleast in part on the second signal indicating elapse of a predeterminedtime period, the instructions include causing deflation of the firstballoon regardless of whether the first signal satisfies the firstcondition.

In some embodiments, the first artery is a femoral artery and the secondartery is a carotid artery. Also in some embodiments, the physicalparameter may include blood pressure of the patient, pressure internalto the first balloon, amount of blockage of the first artery by thefirst balloon, and/or blood flow rate through the first artery.

Furthermore, in some embodiments, the catheter may include a secondballoon, and the logic executed by the processor when accessing theinstructions may further include inflating the second balloon and, basedat least in part on the first signal satisfying a condition, causingdeflation of the second balloon. The instructions may also include,based at least in part on the second signal indicating elapse of apredetermined time period, causing deflation of the second balloonregardless of whether the first signal satisfies the second condition.

Even further, if desired in some embodiments in the first and secondballoons may be inflated simultaneously with each other while in otherembodiments the first balloon is inflated before inflating the secondballoon. In embodiments where the first balloon is inflated beforeinflating the second balloon, the first balloon may be distal to thesecond balloon but can also be proximal to the second balloon.

In another aspect, a control system for an arterial catheter operable toselectively impede blood flow in a first artery to increase blood flowin a second artery includes at least one processor, and at least onecomputer readable storage medium accessible to the processor. Thecomputer readable storage medium bears instructions which when executedby the processor cause the processor to execute logic includingreceiving a first signal representing a physical parameter associatedwith a patient in whom the catheter is disposed, receiving a secondsignal representative of time, and causing inflation of a first balloonon the catheter to impede blood flow in the first artery. Based at leastin part on the second signal indicating elapse of a predetermined timeperiod, the instructions include causing deflation of the first balloon.Based at least in part on the first signal satisfying a first condition,the instructions include causing deflation of the first balloonregardless of whether the second signal indicates the elapse of thepredetermined time period.

In still another aspect, a method includes receiving, at a controlsystem for an arterial catheter operable to selectively impede bloodflow in a first artery to increase blood flow in a second artery, afirst signal representing a physical parameter associated with a patientin whom the catheter is disposed. The method also includes receiving asecond signal representative of time and causing inflation of a firstballoon on the catheter to impede blood flow in the first artery. Basedat least in part on the first signal satisfying a first condition, themethod includes causing deflation of the first balloon. Based at leastin part on the second signal indicating elapse of a predetermined timeperiod, the method includes causing deflation of the first balloon.

The details of the present invention, both as to its structure andoperation, can best be understood in reference to the accompanyingdrawings, in which like reference numerals refer to like parts, and inwhich:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-5 are block diagrams of example catheter systems in accordancewith present principles;

FIGS. 6-12 are exemplary flowcharts of logic to be executed by cathetersystems in accordance with present principles; and

FIGS. 13-19 are exemplary user interfaces (UIs) to be presented on adisplay of a catheter system in accordance with present principles.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to FIG. 1, an exemplary system 10 includes acatheter control system 12, a catheter 14, and a reservoir 16 (sometimesreferred to herein as a “fluid source”). First describing the cathetercontrol system 12, it includes a (e.g., touch-enabled) display 18 andone or more speakers 20 for outputting audio such as audible alerts inaccordance with present principles. The catheter control system 12 alsoincludes and at least one input device 22 such as, e.g., an audioreceiver/microphone, keypad, touchpad, etc. for providing input and/orcommands to a processor 24 (processors sometimes referred to herein as“controllers”) in accordance with present principles (e.g., to provideinput according to the UIs of FIGS. 13-19). Note that the processor 24is understood herein as being configured for controlling the cathetercontrol system 12 in accordance with present principles and indeed theoperations of the system 10.

In addition to the foregoing, the catheter control system 12 also mayalso include a network interface (not shown) for communication over atleast one network (also not shown) such as the Internet, an WAN, a LAN,etc. under control of the processor 24 to e.g. communicate with anotherdevice such as a computer to e.g. provide alerts, status updates, andcatheter information concerning the catheter control system 12 asdisclosed herein to the other computer (e.g. a computer at a nurse'sstation separate from a patient's room in which the system 10 isdisposed). In any case, such a network interface may be, e.g., a wiredor wireless modem or router, or other appropriate interface such as,e.g., a wireless telephony transceiver. In addition to the foregoing,the catheter control system 12 includes a tangible computer readablestorage medium 26 such as disk-based or solid state storage. The medium26 is understood to store the software code and/or logic discussedherein for execution by the processor 24 in accordance with presentprinciples.

Now in reference to the catheter 14, it is to be understood that theexemplary catheter 14 may be in fluid communication with the reservoir16 to inflate and/or deflate one or more balloons 28 on the catheter 14in accordance with present principles via e.g. supply lumen 30 andreturn lumen 32, and also to supply fluid and/or gas to other portionsof the catheter 14 in accordance with present principles. It is to beunderstood that the reservoir 16, though shown as being separate fromthe catheter control system 12, may in some embodiments form part of thesystem 12 and/or be (e.g. mechanically) coupled thereto. The catheter 14may also be in (e.g. electrical) communication with the control system12, either wireless (e.g., using respective transmitters/receivers onthe control system 12 and catheter 14 not shown) or wired via theexemplary wire 34 shown for control of the catheter 14 by the controlsystem 12 and/or for transmitting inputs between the catheter 14 andcontrol system 12 (e.g., such as the biometric parameter data/inputdisclosed herein). Also note that the reservoir 16 may be in (e.g.electrical) communication with the control system 12 so that the controlsystem 12 may control the reservoir 16 and supply of fluid to thecatheter 14 in accordance with present principles.

Additionally, note that although a single supply lumen 30 and returnlumen 32 are shown, it is to be understood that in some embodiments eachof the balloons 28 may be separately and/or independently controlled(e.g. inflated and deflated) such that e.g. the balloons need notnecessarily be in fluid communication with each other and both may beconnected to their own respective supply and return lumens. Thus, therebeing two balloons 28 shown in exemplary FIG. 1, in some embodimentsfour lumens may be employed in such a two-balloon configuration, a firstsupply lumen and a first return lumen both communicating only with afirst of the two balloons, and a second supply lumen and a second returnlumen both communicating only with a second of the two balloons.Notwithstanding, also note that in exemplary embodiments a single lumenmay act as both a supply lumen and return lumen, either for bothballoons or for a single one of the balloons should they beindependently controlled in accordance with present principles.

Additionally, before moving on to FIG. 2 it is to be understood that thecatheter 14 (including its configuration and its fluid and electricalcommunication with the control system 12 and reservoir 16) may be any ofthe catheters described herein and those incorporated by reference asset forth above. Thus, it is to be understood that the system 10 isexemplary and may be used in accordance with the principles and systemsdisclosed herein (as may any of the catheters/catheter systems disclosedherein or incorporated by reference). Thus, for example, even though notspecifically shown in reference to FIGS. 2-5, one or more elementsdescribed in reference to FIG. 1 but omitted from FIGS. 2-5 maynonetheless be included in the systems of FIGS. 2-5 though notspecifically shown for clarity. Furthermore, it is to be understood thatthe controllers and/or processors described herein are configured forexecuting the logic described herein. Last before describing FIG. 2,note that as used herein, “proximal” and “distal” in reference to thecatheter are understood to be relative to the system 12.

Now describing FIG. 2, an exemplary system 38 including an exemplarycatheter 40 is shown. The catheter 40 includes a distal balloon 42, aproximal balloon 44, and a distal tip 46. A fluid source 48 is alsoshown and is understood to be in fluid communication with the catheter40 via the supply/return line(s) 50 to e.g. inflate the balloons 42, 44.A controller 52 is also show for executing logic in accordance withpresent principles to thus e.g. control the catheter and/or inflationand deflation of the balloons 42, 44. The controller 52 is alsounderstood to be configured for receiving input from a blood pressuremonitor 56 that itself receives blood pressure input from one or moreblood pressure sensors 54 (e.g. when the catheter 40 is disposed in anartery of a patient) electrically connected to the blood pressuremonitor 56 to provide input thereto via e.g. at least one blood pressureline 58 extending longitudinally through at least a portion of thecatheter 40 and between the sensor(s) 54 and monitor 56.

As may be appreciated from FIG. 2, the sensor(s) 54 may be disposedagainst, along, or proximate to an inner side of a catheter wall of thecatheter 40 that also includes an outer side e.g. in fluid contact witha patient's blood so that the sensor(s) 54 may thus sense blood pressurethrough the wall of the catheter. Alternatively or in addition tosensing blood pressure though the catheter wall, the catheter wall mayinclude a port(s) so that the sensor(s) 54 may be positioned at orproximate to the port to thus be in fluid contact with the blood of apatient when disposed in the patient's artery to thereby sense bloodpressure. Furthermore, note that the sensors 54 shown in FIG. 2 areshown as being disposed longitudinally along portions of the catheter 40that do not also include one of the balloons 42, 44 disposed there alongand in some instances are thus disposed along the catheter 40 atportions between the balloons 42, 44. Nonetheless, note that if desiredone of more blood pressure sensors may be disposed longitudinally alonga portion of the catheter including the balloon and may even bepositioned within the balloon itself so that blood pressure may besensed through a balloon wall in accordance with present principles.

Now addressing FIG. 3, a catheter 60 is shown as being disposed in anvessel/artery 62 of a patient in accordance with present principles. Thecatheter 60 includes a proximal balloon 64, a distal balloon 66, and adistal tip 68. Also shown in an imagery probe 70 understood to bedisposed within or proximate to the patient (e.g. but not inside theartery 62). The probe 70 is electrically connected to a controller 72 toprovide input thereto via a line 74. Thus, in accordance with presentprinciples, the imagery probe 70 may be positioned in or near thepatient at or proximate to the artery 62 such that occlusion (e.g.,partial or full) of the artery 62 may be determined by the controller 72based on imagery from the probe 70. The controller 72 may thus providean indication of occlusion (e.g. on a display such as the display 18described above) in a percentage parameter (e.g. the amount of occlusionindicated as a percentage). The probe 70 may be, for example, anultrasonic probe, or it may be a probe that senses radiopaque dye thathas been injected either into the patient's bloodstream, oralternatively into the balloons, or it may be another appropriateimaging probe.

Continuing the detailed description in reference to FIG. 4, a catheter76 is shown as being disposed in an vessel/artery 78 of a patient inaccordance with present principles. The catheter 76 includes a proximalballoon 80, a distal balloon 82, and a distal tip 84. Also shown aretemperature and/or flow rate sensors 86 disposed against, along, orproximate to an inner side of a catheter wall of the catheter 76 thatalso includes an outer side e.g. in fluid contact with a patient's bloodin the artery 78 so that the sensors 86 may gather input/measurements(e.g. temperature and/or blood flow rate) regarding cardiac output inaccordance with present principles and provide the measurements to acontroller 88 electrically connected thereto via line 90 extendinglongitudinally along the catheter 76, it being understood that thecontroller 88 is also electrically connected to temperature controller92 via line 94.

Thus, for example, cardiac output (e.g. blood flow) may be measuredusing a temperature differential between two or more temperature signalsfrom sensors 86 disposed along different portions of the catheter 76 andaccordingly e.g. blood flow may be inversely proportional to thetemperature differential/change in temperature. Nonetheless, note thatports may also be included on the catheter 76 along portions of thecatheter wall where the sensors 86 are disposed such that the sensors 86may be in fluid contact with the patient's blood via the ports to gathermeasurements in accordance with present principles. Further note that inembodiments where blood passes through e.g. a portion of the catheter 76itself, measurements may be taken by the sensors according totemperature/flow within the portion (it being understood that similarobservations apply to the measurements gathered using the catheter 40described above as well).

Now addressing FIG. 5, yet another exemplary catheter 96 is shown. Thecatheter 96 includes a proximal balloon 100, a distal balloon 102, and adistal tip 104. Also shown is at least one sensors 106 located inside aballoon(s) such as the distal balloon 104 for measuring (e.g.interior/internal) balloon pressure of the balloon in which the sensor106 is disposed. The one or more sensors 106 are thus electricallyconnected to a pressure sensor unit 108 via line 110 that extendslongitudinally along at least an inner portion of the catheter 96 toprovide input thereto, where the pressure sensor unit 108 is itselfelectrically connected to a controller 112 via a line 114 for providinginput thereto on balloon pressure (e.g. for the controller 112 toconfigure the catheter 96 and specifically one or more of the balloonsfor a desired inflation pressure, artery occlusion, and/or to address acatheter leak and/or to prevent the balloon from bursting or rupturing).Each balloon can have its own internal pressure sensor.

Continuing the detailed description in reference to FIG. 6, an exemplaryflow chart of logic for inflating at least a distal balloon of acatheter in accordance with present principles is shown. Beginning atblock 120, the distal balloon is inflated at an (e.g. constant orpulsed) inflation rate. Then at block 122 the logic observes and/ormonitors at least one biometric parameter such as those discussed above(e.g., blood pressure, vessel occlusion, cardiac output, interiorballoon pressure, etc.). Thereafter, at decision diamond 124, the logicdetermines whether at least one of the biometric parameters has beensatisfied—e.g., that it is out of (e.g., above or below) an acceptable,preferred, and/or normal level or range (e.g. as input by a physician tothe system processor). If a positive determination is made at diamond124, the logic moves to block 126 where the logic deflates the distalballoon and even provides an alarm (e.g. a visual alarm via a displaysuch as the display 18 described above and/or audible alarm such as abell or emergency tone via a speaker such as the speaker 20 describedabove). If, however, a negative determination is made at diamond 124,the logic instead proceeds to decision diamond 128.

At diamond 128, the logic determines whether a maximum time (e.g.threshold) has been reached/satisfied for inflation of the distalballoon (e.g. either or both of the maximum time that inflation ispermitted or safe, and/or the maximum time that the balloon is permittedto remain inflated once a desired inflation pressure has been reached).If a positive determination is made at diamond 128, then the logicproceeds to block 130 where the logic deflates the distal balloon andeven provides an alarm as set forth above regardless of whether one ormore biometric parameters are satisfied. If, however, a negativedetermination is made at diamond 128, the logic instead moves to block132 where the balloon inflation is maintained. The logic then revertsback to diamond 124 thereafter and proceeds from diamond 124.

Now addressing FIG. 7, an exemplary flow chart of logic for inflatingproximal and distal balloons of a catheter in accordance with presentprinciples is shown. Beginning at block 140, the distal balloon of acatheter is inflated at an inflation rate. The logic then moves to block142 where the logic observes and/or monitors at least one biometricparameter such as those discussed above. Thereafter, the logic moves todecision diamond 144 where the logic determines whether the at least oneof the biometric parameters has been satisfied for inflating theproximal balloon of the catheter (such as, e.g., cerebral blood flowover a baseline, there being an inadequate cerebral blood flow increase,or to reduce construction/occlusion using the distal balloon to thus notcomplete block an artery at or around the distal balloon). If at diamond144 the logic determines that the at least one biometric parameter hasnot been satisfied for inflating the proximal balloon (e.g. a conditionexists based on the biometric parameter where it is not appropriate/safeto inflate the proximal balloon), the logic moves to decision diamond146.

At diamond 146, the logic determines whether a maximum time (e.g.threshold) has been reached/satisfied for inflation of the distalballoon (e.g. either or both of the maximum time that inflation ispermitted or safe, and/or the maximum time that the balloon is permittedto remain inflated once a desired inflation has been reached) regardlessof whether a biometric parameter for the proximal balloon has beensatisfied. If a positive determination is made at diamond 146, then thelogic proceeds to block 148 where the logic deflates distal balloon andprovides an alarm as set forth above. If, however, a negativedetermination is made at diamond 146, the logic instead moves to block150 where the balloon inflation is maintained. The logic then revertsback to block 142 from block 150 and proceeds accordingly.

Continuing in reference to FIG. 7 but referring back to decision diamond144 for deciding whether at least one biometric parameter has beensatisfied for inflating the proximal balloon, should a positive ratherthan a negative determination be made thereat, the logic proceeds toblock 152 instead of decision diamond 146. At block 152, the logic thusinflates the proximal balloon of the catheter and then moves to decisiondiamond 154. At diamond 154 the logic determines whether at least onebiometric parameter has been satisfied for deflating the proximalballoon in accordance with present principles. If a positivedetermination is made, the logic then moves to block 156 where the logicdeflates the proximal balloon and then moves to diamond 162, which willbe described shortly.

However, before describing diamond 162, reference is again made todecision diamond 154 where, should a negative determination be maderather than a positive one regarding whether at least one biometricparameter has been satisfied for deflating the proximal balloon, thelogic instead moves to decision diamond 158. At decision diamond 158,the logic determines whether a maximum time (e.g. threshold) has beenreached/satisfied in accordance with present principles for deflatingboth the proximal and distal balloons (e.g., successively orsimultaneously) e.g. regardless of whether a biometric parameter hasbeen satisfied for deflating the proximal balloon or both balloons. If apositive determination is made at diamond 158, the logic proceeds toblock 160 and deflates both balloons and provides at least one alarm. Ifa negative determination is made, the logic instead moves to diamond162.

At decision diamond 162 and regardless of whether the logic proceededthereto from block 156 or diamond 158, the logic determines whether atleast one biometric parameter has been satisfied for deflating thedistal balloon. If a positive determination is made at diamond 162, thelogic moves to block 164 where the logic deflates the distal balloon andthen moves to block 170, which will be described shortly. However, if anegative determination is made at diamond 162, the logic proceeds todiamond 166 where the logic determines whether a maximum time (e.g.threshold) has been reached/satisfied in accordance with presentprinciples for deflating at least one of the proximal and distalballoons (e.g. regardless of a biometric parameter being satisfied).Note that if the logic proceeded to diamond 166 along a path includingblock 156, then at diamond 166 the determination involves determiningwhether to deflate only the distal balloon since the proximal one wasdeflated at block 156. Also note that if the logic proceeded to diamond166 along a path including diamond 158, then at diamond 166 thedetermination involves determining whether to deflate both the proximaland distal balloons because in such a case the logic has yet to deflateeither one.

Regardless, if a positive determination is made at diamond 166, thelogic proceeds to block 168 where the logic deflates one or bothballoons and provides at least one alarm. However, if a negativedetermination is made at diamond 166, the logic instead moves to block170. At block 170 and regardless of whether the logic has moved theretofrom block 164 or diamond 166, the logic continues to monitor at leastone biometric parameter and/or time in accordance with presentprinciples and regardless of the proximal and distal balloonconfigurations being inflated, deflated, or any combination thereofdepending on which path may have been taken in the logic flow of FIG. 7.

Now in reference to FIG. 8, an exemplary flow chart of logic forinflating at least a proximal balloon of a catheter in accordance withpresent principles is shown. Beginning at block 172, the proximalballoon is inflated at an (e.g. constant or pulsed) inflation rate. Thenat block 174 the logic observes and/or monitors at least one biometricparameter such as those discussed above (e.g., blood pressure, vesselocclusion, cardiac output, interior balloon pressure, etc.). Thereafter,at decision diamond 176, the logic determines whether the at least oneof the biometric parameters has been satisfied—e.g., that it is out of(e.g., above or below) an acceptable, preferred, and/or normal level orrange. If a positive determination is made at diamond 176, the logicmoves to block 178 where the logic deflates the proximal balloon andeven provides an alarm (e.g. a visual alarm via a display such as thedisplay 18 described above and/or audible alarm such as a bell oremergency tone via a speaker such as the speaker 20 described above).If, however, a negative determination is made at diamond 176, the logicinstead proceeds to decision diamond 180.

At diamond 180, the logic determines whether a maximum time (e.g.threshold) has been reached/satisfied for inflation of the proximalballoon (e.g. either or both of the maximum time that inflation ispermitted or safe, and/or the maximum time that the balloon is permittedto remain inflated once a desired inflation has been reached) regardlessof the biometric parameter being satisfied. If a positive determinationis made at diamond 180, then the logic proceeds to block 182 where thelogic deflates the proximal balloon and even provides an alarm as setforth above. If, however, a negative determination is made at diamond180, the logic instead moves to block 184 where the balloon inflation ismaintained. The logic then reverts back to diamond 176 thereafter andproceeds accordingly.

Turning now to the flow chart shown in FIG. 9, an exemplary flow chartof logic for inflating distal and proximal balloons of a catheter inaccordance with present principles is shown but, in contrast to FIG. 7,in FIG. 9 the proximal balloon is inflated first. Thus, beginning atblock 190, the proximal balloon of a catheter is inflated at aninflation rate. The logic then moves to block 192 where the logicobserves and/or monitors at least one biometric parameter such as thosediscussed above. Thereafter, the logic moves to decision diamond 194where the logic determines whether the at least one of the biometricparameters has been satisfied for inflating the distal balloon of thecatheter. If at diamond 194 the logic determines that the at least onebiometric parameter has not been satisfied for inflating the distalballoon (e.g. a condition exists based on the biometric parameter whereit is not appropriate/safe to inflate the distal balloon), the logicmoves to decision diamond 196.

At diamond 196, the logic determines whether a maximum time (e.g.threshold) has been reached/satisfied for inflation of the proximalballoon (e.g. either or both of the maximum time that inflation ispermitted or safe, and/or the maximum time that the balloon is permittedto remain inflated once a desired inflation has been reached). If apositive determination is made at diamond 196, then the logic proceedsto block 198 where the logic deflates the proximal balloon and providesan alarm as set forth above. If however, a negative determination ismade at diamond 196, the logic instead moves to block 200 where theballoon inflation is maintained. The logic then reverts back to block192 from block 200 and proceeds accordingly.

Continuing in reference to FIG. 9 but referring back to decision diamond194 for deciding whether at least one biometric parameter has beensatisfied for inflating the distal balloon, should a positive ratherthan a negative determination be made thereat, the logic proceeds toblock 202 instead of decision diamond 196. At block 202, the logic thusinflates the distal balloon of the catheter and then moves to decisiondiamond 204. At diamond 204 the logic determines whether at least onebiometric parameter has been satisfied for deflating the distal balloonin accordance with present principles. If a positive determination ismade, the logic then moves to block 206 where the logic deflates thedistal balloon and then moves to diamond 212, which will be describedshortly.

However, before describing diamond 212, reference is again made todecision diamond 204 where, should a negative determination be maderather than a positive one regarding whether at least one biometricparameter has been satisfied for deflating the distal balloon, the logicinstead moves to decision diamond 208. At decision diamond 208, thelogic determines whether a maximum time (e.g. threshold) has beenreached/satisfied in accordance with present principles for deflatingboth the distal and proximal balloons (e.g., successively orsimultaneously) regardless of whether a biometric parameter has beensatisfied for deflating the distal balloon or both balloons. If apositive determination is made at diamond 208, the logic proceeds toblock 210 and deflates both balloons and provides at least one alarmaccordingly. If a negative determination is made, the logic insteadmoves to diamond 212.

At decision diamond 212 and regardless of whether the logic proceededthereto from block 206 or diamond 208, the logic determines whether atleast one biometric parameter has been satisfied for deflating theproximal balloon. If a positive determination is made at diamond 212,the logic moves to block 214 where the logic deflates the proximalballoon and then moves to block 220, which will be described shortly.However, if a negative determination is made at diamond 212, the logicproceeds to diamond 216 where the logic determines whether a maximumtime (e.g. threshold) has been reached/satisfied in accordance withpresent principles for deflating at least one of the proximal and distalballoons and regardless of a biometric parameter being satisfied. Notethat if the logic proceeded to diamond 216 along a path including block206, then at diamond 216 the determination involves determining whetherto deflate only the proximal balloon since the distal one was deflatedat block 206. Also note that if the logic proceeded to diamond 216 alonga path including diamond 208, then at diamond 216 the determinationinvolves determining whether to deflate both the distal and proximalballoons because in such a case the logic has yet to deflate either one.

Regardless, if a positive determination is made at diamond 216, thelogic proceeds to block 218 where the logic deflates one or bothballoons accordingly and provides at least one alarm. However, if anegative determination is made at diamond 216, the logic instead movesto block 220. At block 220 and regardless of whether the logic has movedthereto from block 214 or diamond 216, the logic continues to monitor atleast one biometric parameter and/or time in accordance with presentprinciples and regardless of the distal and proximal balloonconfigurations being inflated, deflated, or any combination thereofdepending on which path may have been taken in the logic flow of FIG. 9.

Continuing the detailed description in reference to FIG. 10, anexemplary flow chart of logic for inflating at least a distal balloon ofa catheter in accordance with present principles is shown. Beginning atblock 230, the distal balloon is inflated at an (e.g. constant orpulsed) inflation rate. Then at block 232 the logic observes and/ormonitors time (e.g. based on a threshold) in accordance with presentprinciples, e.g. either time while inflating or total time from thebeginning of inflation and continuing after inflation ceases but whilethe distal balloon is still in an at least partially inflatedconfiguration once a desired inflation has been reached. The logic thenmoves to decision diamond 234 where the logic determines whether thetime(s) described immediately above is “up” in that a determination ismade (e.g., the time(s) described herein has transpired and/or expiredsuch that a determination is made) as to whether the distal balloonshould be deflated based on the time(s), e.g. as determined by aphysician and input to the system executing the present logic. If apositive determination is made the logic then moves to block 236 wherethe logic deflates the distal balloon and provides at least one alarm inaccordance with present principles. However, if a negative determinationis made at diamond 234, the logic instead moves to diamond 238.

At diamond 238 the logic determines whether at least one biometricparameter such as those discussed above has been satisfied for deflation(e.g., regardless of whether time(s) is up) in accordance with presentprinciples. If a positive determination is made at diamond 238, thelogic proceeds to block 240 where the logic deflates the distal balloonand provides an alarm in accordance with present principles. If,however, a negative determination is made at diamond 238, the logicinstead proceeds to block 242 where the distal balloon inflation ismaintained. The logic then reverts back to diamond 234 thereafter andproceeds accordingly.

Moving to FIG. 11, yet another flow chart is shown, this one pertainingto inflation and deflation of proximal and distal balloons based on timebut also deflating the balloons regardless of time if one or morebiometric parameters are satisfied. It is to be understood that asdescribed below, balloon number one may be the proximal balloon of acatheter and balloon number two the distal balloon of a catheter, thoughpresent principles recognize that in other embodiments the reverse maybe the case in that balloon number one may be the distal balloon whileballoon number two may be the proximal balloon. Regardless, the logic ofFIG. 11 begins at block 250, the logic inflates balloon number one foran inflation time in accordance with present principles. The logic thenmoves to block 252 where a do loop is entered while balloon number oneis inflated. The logic thereafter proceeds to block 254 where the logicmonitors at least one biometric parameter in accordance with presentprinciples, and then moves to decision diamond 256 where the logicdetermines whether at least one of the at least one monitored biometricparameters is bad in accordance with present principles (e.g. outside ofan accepted range for the biometric parameter during which it is stillsafe and/or preferable that the balloon be inflated).

If a positive determination is made at diamond 256 (e.g., that one ofthe biometric parameters is outside the acceptable range), then thelogic moves to block 258 where the logic deflates balloon number one andprovides an alarm in accordance with present principles. However, if anegative determination is made at diamond 256, the logic instead movesto block 260 where the logic inflates balloon number two e.g. after achange in time (e.g. at a time after the first balloon was inflated).Thereafter, the logic proceeds to block 262 where, while both balloonsare inflated, a do loop is entered.

The logic then proceeds to block 264 where the logic monitors at leastone biometric parameter (e.g. for each balloon using e.g. sensors ineach balloon, where the biometric parameter being measured need not bethe same type for each balloon but nonetheless may be if desired). Afterblock 264, the logic proceeds to decision diamond 266 where the logicdetermines whether at least one of the at least one monitored biometricparameters is bad in accordance with present principles (e.g. outside ofan accepted range for the biometric parameter during which it is stillsafe and/or preferable that the balloon be inflated).

If a positive determination is made at diamond 266 (e.g., that one ofthe biometric parameters is outside the acceptable range), then thelogic moves to block 268 where the logic deflates the balloons andprovides an alarm in accordance with present principles. However, if anegative determination is made at diamond 266, the logic instead movesto block 270 where the logic maintains inflation of the balloons untilsuch time each balloon should be deflated at the end of a deflationperiod (e.g. predetermined) for that particular balloon or for bothballoons.

Before moving on to FIG. 12, note that in the context of FIG. 11, timemay nonetheless also be monitored as described herein such that one orboth of balloons one and two may be deflated based on time regardless ofa biometric parameter being satisfied as determined at diamonds 256 and266. Furthermore, note that in addition to or in lie of makingdeterminations based on biometric parameters at decision diamonds 256and 266, the determinations at these diamonds may be made based on time(and e.g. after such determinations based on time another determinationmay be made regardless of time based on one biometric parameter).

Now in reference to FIG. 12, another exemplary flow chart of logic forinflating at least a proximal balloon of a catheter in accordance withpresent principles is shown. Beginning at block 280, the proximalballoon is inflated at an (e.g. constant or pulsed) inflation rate. Thenat block 282 the logic observes and/or monitors time (e.g. based on athreshold) in accordance with present principles, e.g. either time whileinflating or total time from the beginning of inflation and continuingafter inflation ceases but while the proximal balloon is still in an atleast partially inflated configuration once a desired inflation has beenreached. The logic then moves to decision diamond 284 where the logicdetermines whether the time described immediately above is “up” in thata determination is made (e.g., the time(s) described herein hastranspired and/or expired such that a determination is made) as towhether the proximal balloon should be deflated based on the time(s),e.g. as determined by a physician and input to the system executing thepresent logic. If a positive determination is made the logic then movesto block 286 where the logic deflates the proximal balloon and providesat least one alarm in accordance with present principles. However, if anegative determination is made at diamond 284, the logic instead movesto diamond 288.

At diamond 288 the logic determines whether at least one biometricparameter such as those discussed above has been satisfied for deflation(e.g., regardless of whether time is up) in accordance with presentprinciples. If a positive determination is made at diamond 288, thelogic proceeds to block 290 where the logic deflates the proximalballoon and provides an alarm in accordance with present principles. If,however, a negative determination is made at diamond 288, the logicinstead proceeds to block 292 where the proximal balloon inflation ismaintained. The logic then reverts back to diamond 284 thereafter andproceeds accordingly.

Before moving on to FIGS. 13-19, it is to be understood that althoughnot explicitly shown on the face of FIGS. 6-12, present principlesrecognize that when inflating one or more balloons in accordance withpresent principles at e.g. an inflation rate, inflation may be stoppedonce e.g. a specified (e.g., predetermined as input and/or determined bya physician prior to inflation) pressure in the balloon has beenreached. Furthermore, present principles recognize that while inflatingand/or once the specified inflation level/pressure has been reached,error checking may be performed by the processor executing the logicdiscussed above to e.g. identify balloon leaks and other mechanicaland/or electrical (e.g. computer system) errors, and that uponidentification and/or determination of an error, inflation may stop evenif before the desired balloon pressure is reached.

Further in reference to FIGS. 6-12 and although not explicitly shown intheir face, it is to be understood that balloon inflation may bemaintained in between steps of inflating and then deflating theballoons. Thus, e.g., the logic discussed herein may include inflating aballoon in accordance with present principles, then maintaining thecurrent pressure (e.g. reached during inflation) for e.g. a thresholdtime and/or predetermined time, and then deflating the balloon(s) inaccordance with present principles.

Continuing the detailed description in reference to FIGS. 13-19,exemplary user interfaces (UIs) that may be presented on e.g. a displayof a catheter system such as the display 18 in accordance with presentprinciples is shown. Thus, it is to be understood that the UIs of FIGS.13-19 may be used in conjunction with logic executed by a processor suchas the processor 24 and as represented by the exemplary flow chartsdescribed above to undertake present principles (e.g., the UIs may bemanipulated to provide input to a system processor such as the processor24 to undertake/execute a function in accordance with present principlessuch as e.g. a distal balloon deflation based on time or user input).

Beginning first with FIG. 13, a UI 300 is shown. The UI 300 includes aprompt 302 regarding whether to begin inflation, along with a yesselector 304 selectable to cause inflation to begin for one or moreballoons in accordance with present principles, and a no selector 306selectable to provide input to the system to not begin inflation.

FIG. 14 shows a UI 308 including an indicator 310 that at least a firstballoon is inflating. Also shown is a representation 312 of a catheter(e.g. an icon representation) that includes bi-directional arrows 314vertically disposed within the representation 312 and pointing away fromeach other (e.g. up and down) to indicate that the first balloon of therepresentation in which the arrows 314 are disposed is inflating (e.g.in the present instance, indicating that the proximal balloon isinflating). Also shown is a cancel selector element 316 selectable tocancel and/or stop the inflation (e.g., a manual override) and/or tocause the balloon to deflate. Furthermore, the UI 308 includes aparameter indicator 318 indicating a (e.g. current) biometric parameterbeing monitored in accordance with present principles, and an elapsedtime indicator 320 indicating e.g. the time elapsed since the start ofthe balloon inflation.

Moving on to FIG. 15, an exemplary UI 322 is shown for indicating that asecond balloon of a catheter is inflating in accordance with presentprinciples, in this case the distal balloon, as represented by indicator324. Also shown is a representation 326 of a catheter that includesbi-directional arrows 328 similar to the arrows 314 described above inthat they indicate that a balloon is inflating, in this case the second,distal balloon. A cancel selector element 330 is also shown forcanceling and/or stopping inflation of at least the second balloon, butmay also be selectable for canceling and/or stopping inflation of bothballoons and/or deflating them. Furthermore, the UI 322 includes pluralparameter indicators 332 indicating respective (e.g. current) biometricparameters being monitored in accordance with present principles foreach of the balloons (though in addition to or in lieu of the foregoing,a cumulative biometric parameter and/or overall biometric parameter maybe presented). Also shown is an elapsed time indicator 334 indicatinge.g. the time elapsed since the start of the second balloon inflation,but in some instances may indicate the time elapsed since the beginningof inflation of the first balloon.

Continuing in reference to FIG. 16, a deflation UI 336 is shown forindicating that the first balloon is deflating, as indicated byindicator 337. Thus, a representation 338 of a catheter includesbi-directional arrows 340 vertically disposed within the representation338 and pointing toward each other (e.g. down and up toward the middleof the arrow) to indicate that the first balloon is deflating (e.g. inthe present instance, indicating that the proximal balloon isdeflating). Also shown is a cancel selector element 342 selectable tocancel and/or stop the deflation (e.g., a manual override) to thusmaintain an at least partial inflation of the balloon, and/or to causethe balloon to re-inflate. Furthermore, the UI 336 includes a parameterindicator 344 indicating a (e.g. current) biometric parameter beingmonitored in accordance with present principles, and an elapsed timeindicator 346 indicating e.g. the time elapsed since the start of theballoon deflation, though in other instances it may indicate the totaltime the balloons(s) has been at least partially inflated since itsinitial inflation began.

Now in reference to FIG. 17, an exemplary UI 348 is shown for indicatingthat a second balloon of a catheter is deflating in accordance withpresent principles, in this case the distal balloon, as represented byindicator 350. Also shown is a representation 352 of a catheter thatincludes bi-directional arrows 354 similar to the arrows 340 describedabove in that they indicate that a balloon is deflating, in this casethe second, distal balloon. A cancel selector element 356 is also shownfor canceling and/or stopping deflation of at least the second balloonto thus maintain an at least partial inflation of the balloon, but mayalso be selectable for canceling and/or stopping deflation of bothballoons and/or re-inflating one or both balloons. Furthermore, the UI348 includes plural parameter indicators 358 indicating respective (e.g.current) biometric parameters being monitored in accordance with presentprinciples for each of the balloons (though in addition to or in lieu ofthe foregoing, a cumulative biometric parameter and/or overall biometricparameter may be presented). Also shown is an elapsed time indicator 360indicating e.g. the time elapsed since the start of the second balloondeflation, though in other instances it may indicate the total time theballoon(s) has been at least partially inflated since its initialinflation began.

Turning now to FIG. 18, a UI 362 is shown indicating that both theproximal and distal balloons of a catheter in accordance with presentprinciples are inflated, as represented by indicator 364 andrepresentation 366 of a catheter showing two balloons in an (e.g. atleast partial) inflated configuration. Also shown on the UI 362 is adeflate both selector element 368 selectable to cause deflation of bothballoons at the same time and/or sequential deflation of the balloons.Also shown is a deflate one selector 370 selectable for deflating onlythe first balloon if desired, and a deflate two selector 372 selectablefor deflating only the second balloon if desired. Though not shown, itis to be understood that one or more parameter bio-indicators (e.g. forthe balloons) such as those described above and an elapsed timeindicator such as those described above may also be presented on the UI362 though not specifically shown in FIG. 18.

Concluding the detailed description in reference to FIG. 19, it shows analarm UI 374 presentable when an alarm is to be provided in accordancewith present principles. Thus, the UI 374 includes alarm indicators 376on top and bottom central portions of the UI 374 and a balloon indicator378 indicating that at least one balloon is deflating in accordance withpresent principles. The UI 374 also includes a representation 380 of acatheter including plural bi-directional arrows 382 that may be similarto the arrows 340 and 354 described above for indicating that therespective balloons in which they are shown as being disposed aredeflating. In addition, the UI 374 includes a cancel selector element384 selectable to cancel deflation of one or both balloons, though inother embodiments it is understood to be selectable merely to cause e.g.an audible alarm presented along with the UI 374 to cease soundingand/or to cause the UI 374 to no longer be presented on the display onwhich it is presented while nonetheless still deflating the balloons.Addressing simultaneous inflation of the balloons described herein, itis to be understood that in accordance with present principles, oneballoon may be inflated while the other simultaneously deflated. Last,note that in exemplary embodiments stars 386 or other suitable iconsindicating an alarm (such as e.g. alarm clock icons) may be presented onor proximate to corners of the UI 374 to further indicate an alarm isoccurring.

Regarding any/all of the UIs described above, it is to be understoodthat these UN may include a total maximum or optimal inflation time, aswell as maximum and minimum (e.g. optimal) biometric parameters.Furthermore, different times can be indicated on the UIs for eachballoon (from the start of inflation of each balloon). Indeed, the UIelements described above (as well as the catheter system component andlogic steps) may be combined, changed, and rearranged and thus theexemplary figures above are not to be construed as limiting on theclaims (e.g., a logic step in accordance with present principles may beadded to one figure though not specifically shown in that particularfigure or shown at a different point in the logic than where it is to beadded). Also, note that thresholds may be used in accordance withpresent principles such that, e.g., determinations are made based onbiometric parameter and/or time thresholds being met.

Without reference to any particular figure, it is to be understood thatthe procedures and determinations detailed in U.S. application Ser. No.11/042,639, incorporated herein by reference, may be incorporated intothe logic discussed herein. For example, during balloon inflation, ifdesired the processor executing logic in accordance with presentprinciples may pulse the balloons to cause a periodic release ofconstrictions to “reset” the body and/or blood flow. As another example,orientation and positioning of a catheter may be checked by TEE, TTE, orultrasound and these can even in part form biometric parameters inaccordance with present principles.

Before concluding, it is to be understood that the inflation times andrates described herein can be different lengths of time and inflationrates in exemplary embodiments where, e.g. one balloon is inflated andthen another is inflated. Addressing simultaneous inflation of theballoons described herein, it is to be understood that in accordancewith present principles, one balloon may be inflated while the othersimultaneously deflated. Also note that blood flow rate in accordancewith present principles may be measured at various portions of the bodyif it is not based on cardiac output as described herein. Further still,note that fluoroscopic dye can be used in accordance with presentprinciples (e.g. inserted into an artery/blood stream) to detect bloodflow (e.g., blood flow augmentation) and accordingly blood flow may be abiometric parameter in accordance with present principles determined atleast in part on (e.g. detection of) flow of fluoroscopic dye.Addressing simultaneous inflation of the balloons described herein, itis to be understood that in accordance with present principles, oneballoon may be inflated while the other simultaneously deflated.

In addition to the foregoing, more than two balloons may be used in someinstances (e.g., three) and may be controlled in accordance with theprinciples set forth herein. Further note that occlusion or constructionof e.g. an artery using proximal and distal balloons in accordance withpresent principles may but need not necessarily be full occlusion andthat partial occlusion may in some instances be appropriate.

Last, note that present principles recognize that the storage mediumsdiscussed herein may store e.g. information specific to a patient and/ora procedure performed on the patient, and that therefore the logicdiscussed above may incorporate such information when inflating anddeflating balloons (e.g. inflate a balloon to a certain level based on aprevious inflation level previously applied to that particular patientin another procedure) in accordance with present principles. Forinstance, the results of each procedure (e.g. inflation rates, times,levels, etc.) may be stored for review by a physician when evaluating aparticular patient that has undergone the procedure.

While the particular CONTROL SYSTEM FOR ARTERIAL CATHETER is hereinshown and described in detail, it is to be understood that the subjectmatter which is encompassed by the present invention is limited only bythe claims.

What is claimed is:
 1. Control system for an arterial catheter operableto selectively impede blood flow in a first artery to augment blood flowin a second artery, comprising: at least one processor; at least onecomputer readable storage medium accessible to the processor and bearinginstructions which when executed by the processor cause the processor toexecute logic comprising: receiving a first signal representing aphysical parameter associated with a patient in whom the catheter isdisposed; receiving a second signal representative of time; causinginflation of a first balloon on the catheter to impede blood flow in thefirst artery; based at least in part on the first signal satisfying afirst condition, causing deflation of the first balloon; and based atleast in part on the second signal indicating elapse of a predeterminedtime period, causing deflation of the first balloon regardless ofwhether the first signal satisfies the first condition.
 2. The system ofclaim 1, wherein the physical parameter includes blood pressure of thepatient.
 3. The system of claim 1, wherein the physical parameterincludes pressure internal to the first balloon.
 4. The system of claim1, wherein the physical parameter includes amount of blockage of thefirst artery by the first balloon.
 5. The system of claim 1, wherein thephysical parameter includes blood flow rate through the first artery. 6.The system of claim 1, wherein the first artery is a femoral artery andthe second artery is a carotid artery.
 7. The system of claim 1, whereinthe catheter includes a second balloon and the logic executed by theprocessor when accessing the instructions further includes: inflatingthe second balloon; based at least in part on the first signalsatisfying a condition, causing deflation of the second balloon; andbased at least in part on the second signal indicating elapse of apredetermined time period, causing deflation of the second balloonregardless of whether the first signal satisfies the second condition.8. The system of claim 1, wherein the catheter includes a second balloonand the logic executed by the processor when accessing the instructionsfurther includes: inflating the first and second balloons simultaneouslywith each other.
 9. The system of claim 1, wherein the catheter includesa second balloon and the logic executed by the processor when accessingthe instructions further includes: inflating the first balloon beforeinflating the second balloon.
 10. The system of claim 9, wherein thefirst balloon is distal to the second balloon.
 11. The system of claim9, wherein the first balloon is proximal to the second balloon. 12.Control system for an arterial catheter operable to selectively impedeblood flow in a first artery to increase blood flow in a second artery,comprising: at least one processor; at least one computer readablestorage medium accessible to the processor and bearing instructionswhich when executed by the processor cause the processor to executelogic comprising: receiving a first signal representing a physicalparameter associated with a patient in whom the catheter is disposed;receiving a second signal representative of time; causing inflation of afirst balloon on the catheter to impede blood flow in the first artery;based at least in part on the second signal indicating elapse of apredetermined time period, causing deflation of the first balloon; andbased at least in part on the first signal satisfying a first condition,causing deflation of the first balloon regardless of whether the secondsignal indicates the elapse of the predetermined time period.
 13. Thesystem of claim 12, wherein the physical parameter includes bloodpressure of the patient.
 14. The system of claim 12, wherein thephysical parameter includes pressure internal to the first balloon. 15.The system of claim 12, wherein the physical parameter includes amountof blockage of the first artery by the first balloon.
 16. The system ofclaim 12, wherein the physical parameter includes blood flow ratethrough the first artery.
 17. The system of claim 12, wherein the firstartery is a femoral artery and the second artery is a carotid artery.18. The system of claim 12, wherein the catheter includes a secondballoon and the logic executed by the processor when accessing theinstructions further includes: inflating the second balloon; based atleast in part on the second signal indicating elapse of a predeterminedtime period, causing deflation of the second balloon; and based at leastin part on the first signal satisfying a condition, causing deflation ofthe second balloon regardless of whether the second signal indicates theelapse of the predetermined time period.
 19. The system of claim 12,wherein the catheter includes a second balloon and the logic executed bythe processor when accessing the instructions further includes:inflating the first and second balloons simultaneously with each other.20. The system of claim 12, wherein the catheter includes a secondballoon and the logic executed by the processor when accessing theinstructions further includes: inflating the first balloon beforeinflating the second balloon.
 21. The system of claim 20, wherein thefirst balloon is distal to the second balloon.
 22. The system of claim20, wherein the first balloon is proximal to the second balloon.
 23. Amethod, comprising: receiving, at a control system for an arterialcatheter operable to selectively impede blood flow in a first artery toincrease blood flow in a second artery, a first signal representing aphysical parameter associated with a patient in whom the catheter isdisposed; receiving a second signal representative of time; causinginflation of a first balloon on the catheter to impede blood flow in thefirst artery; based at least in part on the first signal satisfying afirst condition, causing deflation of the first balloon; and based atleast in part on the second signal indicating elapse of a predeterminedtime period, causing deflation of the first balloon.
 24. The method ofclaim 23, comprising causing deflation of the first balloon regardlessof whether the first signal satisfies the first condition based at leastin part on the second signal indicating elapse of the predetermined timeperiod.
 25. The method of claim 23, comprising causing deflation of thefirst balloon regardless of whether the second signal indicates theelapse of the predetermined time period based at least in part on thefirst signal satisfying the first condition.